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Registration of medical equipment.


All medical products exported to Russia must be reviewed and registered by the Russian Federation Ministry of Health (MinZdrav). The medical products must be tested and receive the ministry's approval. The Approval is the necessary requirement to receive the mandatory GOST-R certificate.

All medical products exported to Russia must be reviewed and registered by the Russian Federation Ministry of Health (MinZdrav). The medical products must be tested and receive the ministry's approval. The Approval is the necessary requirement to receive the mandatory GOST-R certificate.

Registration certificate is issued for medical equipment, instruments and materials. Use of any medical product in Russia without registration in Roszdravnadzor is prohibited. Registration is given on the basis of a set of tests and estimations, which confirms the quality, efficiency, and safety of the product. Time of validity of the registration certificate is not limited.

The term of registration is 10 years for medical devices and equipment, and 5 years for medical products.

There are classification of medical equipment in the Russian Federation (according to potential risk of application) .

By this factor classification is made in accordance with GOST R 51609-2000 "Medical products. Classification according to potential risk of application. The norm is also set by the administrative procedure of Federal Service for the Supervision of Public Health and Social Development on the state function to register medical products. .

According to these rules there are 4 classes of potential risks of product application:

  • low risk products
  • average risk products
  • heightened risk products
  • high risk products


    Class 1 - products with a low risk for environment, individual and public health;

    Class 2 - products with average risk for environment, individual and public health. The second class is sub-divided into class 2a and 2b - average and heightened risk, respectively.

    Class 3 - products with high individual risk, average risk for environment and public health;

    Class 4 -products with high risk for environment, individual and public health.




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